Abstract
Original language | English |
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Pages (from-to) | 179-185 |
Number of pages | 7 |
Journal | Critical Care and Resuscitation |
Volume | 15 |
Issue number | 3 |
Publication status | Published - 2013 |
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A protocol for a multicentre randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients with severe sepsis : the BLING II study. / Dulhunty, Joel; Roberts, Jason; Davis, Joshua; Webb, Steven; Bellomo, Rinaldo; Gomersall, Charles; Shirwadkar, Charudatt; Eastwood, Glenn; Myburgh, John; Paterson, David; Starr, Therese; Udy, Andrew; Paul, Sanjoy; Lipman, Jeffrey.
In: Critical Care and Resuscitation, Vol. 15, No. 3, 2013, p. 179-185.Research output: Contribution to journal › Comment/debate › Research
TY - JOUR
T1 - A protocol for a multicentre randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients with severe sepsis
T2 - the BLING II study
AU - Dulhunty, Joel
AU - Roberts, Jason
AU - Davis, Joshua
AU - Webb, Steven
AU - Bellomo, Rinaldo
AU - Gomersall, Charles
AU - Shirwadkar, Charudatt
AU - Eastwood, Glenn
AU - Myburgh, John
AU - Paterson, David
AU - Starr, Therese
AU - Udy, Andrew
AU - Paul, Sanjoy
AU - Lipman, Jeffrey
PY - 2013
Y1 - 2013
N2 - Background and rationale: Beta-lactam antibiotics are largely administered by bolus dosing, despite displaying time-dependent pharmacokinetics and pharmacodynamics and there being a strong rationale for continuous administration. The randomised controlled trials conducted to date comparing the mode of beta-lactam administration have been inconclusive and limited by non-equivalent dosing, unblinded administration and small sample sizes. Objective: A multicentre, randomised controlled trial (the Beta-lactam Infusion Group [BLING] II study) is currently under way, comparing continuous infusion to standard bolus administration of beta-lactam antibiotics in critically ill patients, independent of dose. Design, settings, participants and interventions: BLING II is a Phase IIB, double-blinded, randomised controlled trial recruiting 420 intensive care unit patients with severe sepsis to receive one of three beta-lactam study antibiotics (ticarcillin-clavulanate, piperacillin-tazobactam or meropenem) by either continuous infusion or intermittent bolus administration. Main outcome measures: The primary outcome is ICU-free days at Day 28. Secondary outcomes include 90-day survival, clinical cure 14 days after study antibiotic cessation, organ failure-free days at Day 14 and duration of bacteraemia. Results and conclusions: The study started in July 2012 and will provide clinical evidence as to whether continuous infusion of beta-lactam antibiotics is superior to intermittent bolus administration in critically ill patients with severe sepsis. A Phase III study powered for a survival end point may be justified, based on the results of our study.
AB - Background and rationale: Beta-lactam antibiotics are largely administered by bolus dosing, despite displaying time-dependent pharmacokinetics and pharmacodynamics and there being a strong rationale for continuous administration. The randomised controlled trials conducted to date comparing the mode of beta-lactam administration have been inconclusive and limited by non-equivalent dosing, unblinded administration and small sample sizes. Objective: A multicentre, randomised controlled trial (the Beta-lactam Infusion Group [BLING] II study) is currently under way, comparing continuous infusion to standard bolus administration of beta-lactam antibiotics in critically ill patients, independent of dose. Design, settings, participants and interventions: BLING II is a Phase IIB, double-blinded, randomised controlled trial recruiting 420 intensive care unit patients with severe sepsis to receive one of three beta-lactam study antibiotics (ticarcillin-clavulanate, piperacillin-tazobactam or meropenem) by either continuous infusion or intermittent bolus administration. Main outcome measures: The primary outcome is ICU-free days at Day 28. Secondary outcomes include 90-day survival, clinical cure 14 days after study antibiotic cessation, organ failure-free days at Day 14 and duration of bacteraemia. Results and conclusions: The study started in July 2012 and will provide clinical evidence as to whether continuous infusion of beta-lactam antibiotics is superior to intermittent bolus administration in critically ill patients with severe sepsis. A Phase III study powered for a survival end point may be justified, based on the results of our study.
KW - beta lactam
KW - adult
KW - aged
KW - article
KW - comparative study
KW - controlled clinical trial
KW - controlled study
KW - critical illness
KW - dose response
KW - double blind procedure
KW - female
KW - follow up
KW - human
KW - intensive care
KW - intravenous drug administration
KW - male
KW - methodology
KW - middle aged
KW - multicenter study
KW - phase 2 clinical trial
KW - prospective study
KW - randomized controlled trial
KW - sepsis
KW - treatment outcome
KW - Adult
KW - Aged
KW - beta-Lactams
KW - Critical Care
KW - Critical Illness
KW - Dose-Response Relationship, Drug
KW - Double-Blind Method
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Infusions, Intravenous
KW - Male
KW - Middle Aged
KW - Prospective Studies
KW - Sepsis
KW - Treatment Outcome
M3 - Comment/debate
VL - 15
SP - 179
EP - 185
JO - Critical Care and Resuscitation
JF - Critical Care and Resuscitation
SN - 1441-2772
IS - 3
ER -